This chapter addresses the added protection required by federal regulations when “vulnerable subjects” are used in research. Children, pregnant women, fetuses, neonates, and prisoners are vulnerable subjects as stated in the federal regulations. Federal regulations (45 CFR 46 Subparts B, C, and D) describe the special precautions investigators must take when conducting research on vulnerable subjects. For more information, click the links below:
Subpart B —Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research,
Subpart C —Additional Health and Human Services (HHS) Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects,
Subpart D—Additional HHS Protections for Children Involved as Subjects in Research.
IRBs and researchers must bear in mind that “vulnerability” is a concern that exceeds regulatory definitions. Most individuals and classes of subjects may be vulnerable at some time depending on the research, the situation, the condition and their susceptibility to coercion. Researchers are expected to take special precautions when including individuals who have a compromised ability to understand and/or are vulnerable to coercion. Subparts B, C and D are discussed below.
15.1 Additional HHS Protections for Children Involved as Subjects in Research (45 CFR 46, Subpart D) For clarity, this chapter uses the following terminology:
“Children” are individuals who have not reached the legal age to consent to research treatments or procedures. Under California Law, the legal age is 18 years of age. In California, there are important exceptions which allow individuals under the age of 18 to consent to research and some medical procedures. Thus, in California, additional HHS protections (45CFR46, Subpart D) apply to individuals under 18 years of age. (CFC 3402).
“Minors” are individuals under 18 years of age (CFC 6500).
California Exceptions Permitting Certain Minors to Consent In California, minors (those under 18 years of age) generally may not consent to medical care or treatment, or research involving medical care or treatment, without a parent or legal guardian’s consent. Federal regulations when interpreted with California legal
Chapter 15: Vulnerable Subject Populations USC HSPP Policies and Procedures
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